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A non-invasive, safe and effective treatment that improves pelvic floor muscle contraction and diminishes urine loss in pelvic floor disorders1

Pelvic floor disorders can adversely affect quality of life

Pelvic floor disorders occur when the muscles supporting pelvic organs such as the bladder become weak or damaged

Pelvic floor disorders can cause embarrassment and adversely affect quality of life, as a weak pelvic floor or an inability to properly contract the pelvic floor can often be root causes of urinary incontinence

It is currently estimated that over 5 million women in the UK experience the symptoms of urinary incontinence and of these, half of all sufferers aged between 18 and 65 years of age are moderately or greatly bothered by it2

About one third of women experience urinary incontinence after giving birth, and over 65% of these women are still affected by it 12 years later3

23% of women with urinary incontinence say that it reduces their activity level; 23% state that it adversely affects their sex life; and 31% dress differently because of their symptoms2

Whilst pelvic floor disorders mainly affect women, they can also affect men

1 in 3women can be affected by urinary incontinence during their lifetime

“INNOVO™ has changed my life for the better. I no longer have ‘the fear’ and don’t have to use liners anymore.”

Anne B, 51 years, lived with mixed incontinence for 10 years

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INNOVO™ RESTORE THE FLOOR

INNOVO™ has been developed by Atlantic Therapeutics*, a leading innovator in muscle conditioning and strengthening products, with a 50-year history of delivering effective, clinically proven restorative health solutions in muscle rehabilitation and conditioning.

Innovotherapy, a highly effective treatment for urinary incontinence

INNOVO™ has been developed to treat the root causes

of urinary incontinence and Innovotherapy is the name

of the treatment it delivers. It features two treatment

programmes, one that focuses on improving pelvic

floor muscle contraction and the other on calming

an overactive bladder. Depending on the type of urinary

incontinence (stress, urge or mixed), patients and their

healthcare clinician can choose the most appropriate

programmes and parameters.

Innovotherapy is a non-invasive, safe and effective form

of electrical muscle stimulation. It is clinically proven to

improve pelvic floor muscle contraction and diminish urine

loss in pelvic floor disorders.1

Using an INNOVO™ hand-held controller that is attached

to a two part wearable garment, Innovotherapy produces

highly focused, accurately coordinated and effective pelvic

floor muscle contractions that help rehabilitate the pelvic

floor musculature. Targeted impulses are sent via

conductive pads producing over 180 perfect contractions

per session. Users can actually feel their entire pelvic

floor muscles being “lifted” without having to do any

voluntary activation.

INNOVO™ stimulates the nerve tree as it branches

throughout the pelvic floor

“INNOVO™ offers an innovative, non-invasive solution to women, enabling them to improve their symptoms and considerably reduce involuntary urine loss.”

Dr Julian Spinks GP, with a special interest in continence care

For those using Innovotherapy to treat:

Stress incontinence, it will strengthen the pelvic floor

Urge incontinence, it will help calm an overactive bladder

Mixed incontinence, it will alternate the stress and urge

treatment to strengthen and calm

* Atlantic Therapeutics is the Uro/Gynaecology Division of Bio-Medical Research Limited (BMR)

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A 26-week pilot study of women with stress urinary incontinence who followed the Innovotherapy treatment regimen found significant improvement in their symptoms:

1-hour stress test Average urine loss – weight of pad

24-hour test Average urine loss – weight of pad

Improvement in contractility upon treatment

Innovotherapy decreases urinary loss

-hour stress testAverage urine loss – weight of pad

1

Baseline 4 weeks Baseline 12 weeks

Before After Before After

41.6g 5.8g 21.8g 5.6g

24-hour testAverage urine loss – weight of pad

-hour stress testAverage urine loss – weight of pad

1

Baseline 4 weeks Baseline 12 weeks

Before After Before After

41.6g 5.8g 21.8g 5.6g

24-hour testAverage urine loss – weight of pad

Patients’ pelvic floor muscle contractility improved over 12 weeks of INNOVO™ treatment

The study with patients who followed Innovotherapy for 12 weeks showed:

An improvement in the Modified Oxford Score (standing position) after treatment with

Innovotherapy, where 79% of patients had good or moderate pelvic floor muscle contractions

at 12 weeks, compared with 6% at baseline1

Ultrasound imaging performed on patients throughout the application of Innovotherapy for 8 weeks showed:

An increase in the ability to volitionally contract the pelvic floor while standing, for all patients (below),

which resulted in cranial encroachment on the bladder by the pelvic floor muscle4

Patients had better awareness of the pelvic floor at cessation of stimulation4

Innovotherapy improves muscle contractility

Improvement in contractilityupon treatment

Muscle contraction in pelvic floor(Modified Oxford Score)

0 4

6%0% 0%

29%

50%

31%

12

Patie

nts

Weeks

% Moderate contraction

Good contraction

a. Pelvic floor muscle (PFM) at rest followed; b. attempt at volitional pelvic floor contraction which

results in Valsalva and caudal motion (arrow down); c. PFM at rest; d. PFM contraction elicited by

INNOVO™ while standing, resulting in cranial encroachment of PFM on the bladder (arrow up).

Adapted from Maher et al, 2012.4

A significant improvement in the amount of involuntary urine leaked in 93% of INNOVO™ users after 4 weeks of treatment, where 60% were defined as dry.1

An average 74% reduction in involuntary urine loss over 24 hours after 12 weeks of treatment, where 86% of INNOVO™ users were defined as dry or almost dry.1

(79%)

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An improvement in incontinence quality of life score after 12 weeks of treatment with

Innovotherapy compared with baseline (mean score 47 at baseline compared with 81 at 26 weeks)1A prospective observational study on the impact of Innovotherapy on urinary incontinence and quality of life, in which 48 patients from four French therapy centres participated for a period of 12 weeks, showed:

An improvement in incontinence quality of life score

after 12 weeks of treatment with Innovotherapy

compared with baseline (mean score 64.68 at baseline

compared to 86.85 at 12 weeks)5

An observational study on the impact of Innovotherapy on urinary incontinence and quality of life, in which 104 patients from 25 German therapy centres participated for a period of 14 weeks, showed:

A significant reduction in the proportion of patients

whose everyday lives were severely or moderately

affected by urinary incontinence and a consequent

increase in patients only mildly affected by it6

Innovotherapy significantly improves quality of life

Improvement in 24-hr pad weight testpatient scores

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Improvement in iQOLpatient scores

Assessment Time (Week)0

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Improvement in 24-hr pad weight testpatient scores

Assessment Time (Week)0

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Improvement in iQOLpatient scores

Assessment Time (Week)0

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Improvement in iQOL scoresupon treatment

86.85

64.68

Baseline0

20

40

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80

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Week 12

iQO

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Improvement in 24-hour pad weight test Patient scores

Improvement in incontinence quality of life Patient scores

Incontinence quality of life scores improves over a 12 week period

Reduction of severe and moderate impact of urinary incontinence upon everyday life following Innovotherapy treatment

Treatment with Innovotherapy significantly improves the quality of life scores and reduces urine leaks over a 26-week period

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Reduction in urinary incontinenceupon treatment

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Before After

84Severe/moderateMinorNo effect

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INNOVO™ RESTORE THE FLOOR

On this scale, the quality of life index has improved from 51 to 66 points (average of points)

with similar improvements in the individual domains of ‘prevention and behavioural restrictions’,

‘psychosocial effects’, and ‘social impairments’6

Increase in QOL Indexupon treatment

66 6460

71

57

444951

Total score Prevention &behaviouralrestrictions

Psychosocialeffects

Social impairments

0

102030

8070605040

QO

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dex

“INNOVO™ has changed my life, I can play with my children again.”

Melinda, 34, young mum

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Very good (34%) or good (51%) compliance with Innovotherapy

in 85% of patients as perceived by the doctors participating in the study6

Clinician and patient satisfaction when prescribing and

using Innovotherapy

High compliancewith Innovotherapy

85%

34% “very good”

51% “good”

98% of physicians would

recommend INNOVO™ to

colleagues (n=60)6

90% of patients would

recommend INNOVO™ to

others (n=86)6

High clinician and patient satisfactionwith Innovotherapy

98% 90% PatientsPhysicians

High clinician and patient satisfactionwith Innovotherapy

98% 90% PatientsPhysicians

“I found the device to be very user-friendly, powerful and effective. I am now running with confidence, and I would recommend it to anyone who is suffering with incontinence problems.”

Julie R, 38

Good compliance with Innovotherapy, and recommended by doctors

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INNOVO™ RESTORE THE FLOOR

INNOVO™ is highly effective

After 4 weeks of treatment, 93% of users showed

‘significant improvement’ (greater than 50% reduction)

in the amount of involuntary urine leaked and 60% were

defined as dry1

After 12 weeks of treatment, 86% of subjects were

defined as ‘dry’ or ‘almost dry’ with an average

reduction of 74% in the amount of involuntary urine lost

over 24 hours1

An improvement in incontinence quality of life

score was seen after 12 weeks of treatment with

Innovotherapy compared with baseline (mean score

47 at baseline compared to 81 at 26 weeks)1

The results from INNOVO™ observational studies

confirm that:

The quality of life of users significantly improves after

treatment with the device

Male patients can benefit as much as females

Doctors, physiotherapists and patients alike would all

recommend Innovotherapy6

INNOVO™ is safe

INNOVO™ has been extensively tested and approved by

all relevant European safety authorities

When used in accordance with instructions,

Innovotherapy is safe and has no known side-effects (see

list of contraindications and warnings)

Over half a million treatments have already been

completed by thousands of patients across Europe

INNOVO™ is comfortable

INNOVO™ is a garment based, non-invasive device.

No invasive vaginal or anal electrode probes are involved

It offers a comfortable and convenient treatment

experience in the privacy of the patient’s own home

Stimulation intensity can be easily and precisely adjusted

for each individual user and for each application

The INNOVO™ garment is made of breathable and skin-

friendly material

It is available in various sizes (Small, Medium and Large)

to suit a wide range of male and female shapes

Benefits to patients

INNOVO™ can be used by a wide range of patients

Innovotherapy can be widely used and offers a wide range of benefits to post-pregnancy,

sporty, pre and post-menopausal as well as post-prostatectomy patients experiencing

urinary incontinence

Innovotherapy can be fine-tuned to meet the patient’s needs and requirements. Three types of

treatment regimens are available to treat stress, urge and/or mixed incontinence

Stress Incontinence

Urge Incontinence

Alternate use of stress and urge programmes every other day to obtain a mixed schedule

INNOVO™ offers stress, urge and mixed incontinence treatment programmes

Post-pregnancy Sporty Women Menopause Post-Prostatectomy

Restore the floor

Effective solution, home based therapy, non-invasive, accurate, strenghthen, prevention

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INNOVO™ RESTORE THE FLOOR

References

1) Soeder S, Tunn R. Neuromuscular electrical stimulation (NMES) of the pelvic floor muscles using a non-invasive surface device in the treatment of stress UI (SUI); a pilot study. IUGA Poster Presentation Conference, 2013; Dublin, Ireland.

2) Elneil S. Incontinence and prolapse. In: Annual Report of the Chief Medical Officer: 2014. p. 122–123.

3) MacArthur C, Wilson D, Herbison P, Lancashire RJ, Hagen S, Toozs-Hobson P, et al. UI persisting after childbirth: extent, delivery, history, and effects in a 12-year longitudinal cohort study. International Journal of Obstetrics and Gynaecology 2015 (Epub ahead of print).

4) Maher RM, Caulfield B. A novel externally applied neuromuscular stimulator for the treatment of stress UI in women – a pilot study. Neuromodulation 2013; 16(6): 590-594.

5) Bio-Medical Research (BMR) Health. Summary results: NT Vital compact French registry study (n=48), September 2015.

6) Bio-Medical Research (BMR) Health. Results: observational study on the treatment of stress, urge and mixed incontinence using NEUROTECH VITAL™, April 2013 - February 2014.

2441-0804 Rev.1 Issue Date: 02/16

INNOVO™ actively treats the primary cause of urinary incontinence

INNOVO™ is clinically proven to improve muscle contractility, urinary loss and quality of life

INNOVO™ is a non-invasive, safe and effective treatment for pelvic floor disorders

Restoring the pelvic floor, control and confidence

INNOVO™ from Atlantic Therapeutics

Designed by & manufactured for:

Bio-Medical Research Ltd

Parkmore Business Park West

Galway, Ireland

info@restorethefloor.com

UK: Freephone 0800 0285687

IRL: Freephone 1800 800 045

restorethefloor.com